Efficacy of B-cell depletion with rituximab on oral, ocular and general disease manifestations in patients with primary Sjögren disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004740-31-DK

Enrollment

Registered

2005-11-03

Start date

2005-12-21

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously treated patients with primary Sjögrens disease MedDRA version: 8.0 Level: PT Classification code 10040767

Interventions

Trade Name: MabThera (rituximab) Product Name: MabThera Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: rituximab CAS Number: 174722-31-7 Other descriptive name: MabTh

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Female patients with primary Sjögrens disease Age 18-60 year Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy and lactation Systemic treatment with cytostatics Previous rituximab treatment Active infection that requires antibiotic treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: Treatment efficacy on Sjögrens disease;Secondary Objective: Structural changes from glandula parotis, efficacy on glandula function. Efficacy on glandula function Efficacy on circulating serum autoantibodies. Safety;Primary end point(s): Subjective disease manifestations defined as dryness of mouth and eyes, muscle- and synovial pain and tiredness	—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026